Whole-Body MRI in the Evaluation of Pediatric Malignancies
N/A
21 Years
Both
Lymphoma, Neuroblastoma, Sarcoma
Trial Information
Whole-Body MRI in the Evaluation of Pediatric Malignancies
OBJECTIVES:
Primary
- Compare non-inferior diagnostic performance of whole-body MRI (i.e., combination of
turbo short-tau inversion-recovery (STIR) and out-of-phase imaging) vs conventional
imaging (i.e., the combination of chest CT scan, scintigraphy [bone, gallium,
meta-iodobenzylguanidine (MIBG), or optional fludeoxyglucose F 18 positron emission
tomography (FDG-PET)] and abdominal/pelvic CT scan/MRI as indicated) for detecting
distant metastases for use in staging common tumors in pediatric patients.
Secondary
- Determine the incremental benefit of adding out-of-phase T1-weighted gradient-recalled
echo imaging to turbo STIR for detecting distant disease in these patients.
- Determine, preliminarily, the relative accuracies of FDG-PET, whole-body MRI, and a
combination of FDG-PET and whole-body MRI in detecting stage IV disease in these
patients.
- Determine the effects of multiple factors, including cancer type, site of primary
tumor, and patient age, on diagnostic accuracy of whole-body MRI in these patients.
- Determine the interobserver variability associated with interpreting whole-body MRI
exams for detecting distant metastases in these patients.
OUTLINE: This is a multicenter study.
Patients undergo conventional MRI, CT scan, and/or scintigraphy (e.g., bone,
meta-iodobenzylguanidine [MIBG], or gallium) and experimental whole-body MRI sequences.
Patients may optionally undergo fludeoxyglucose F18 positron emission tomography (FDG-PET).
Patients with a lesion (or lesions) detected on whole-body MRI or FDG-PET at initial staging
that are not confirmed by biopsy or other conventional imaging studies at staging repeat
standard imaging at 3- to 6-month follow-up.
Patients with an abnormality that is considered highly suspicious for a metastasis or when
biopsy proof of that metastasis is obtained receive treatment at the discretion of the
treating physician.
Patients are followed annually for 3 years.
PROJECTED ACCRUAL: A total of 226 patients (45 with neuroblastoma, 54 with rhabdomyosarcoma,
27 with other sarcoma, and 100 with lymphoma) will be accrued for this study within 1 year.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Confirmed diagnosis OR newly diagnosed mass strongly suspected to represent 1 of the
following:
- Rhabdomyosarcoma
- Ewing's sarcoma family of tumors
- Neuroblastoma
- Hodgkin's lymphoma
- Non-Hodgkin's lymphoma
- All imaging examinations (e.g., CT scan, MRI, or scintigraphy) must be performed
within 14 days of each other and within 2 months of any diagnostic or operative
procedure
- Whole body MRI and positron emission tomography (PET) scanning (if PET scan is
being done) must be done before treatment
- Prior CT scan, conventional MRI, bone scintigraphy, gallium scintigraphy, or
meta-iodobenzylguanidine (MIBG) scintigraphy performed at outside institutions
allowed provided the same technical standards specified in this study were
practiced
- Bone scintigraphy required for patients with neuroblastoma, rhabdomyosarcoma, or
other sarcomas
- Gallium scintigraphy not required in lymphoma patients if PET scan is performed
- No CNS primary tumor
PATIENT CHARACTERISTICS:
Age
- 21 and under
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Cardiovascular
- No active cardiac pacemakers
Other
- Not pregnant or nursing
- No prior malignancy
- No uncontrolled diabetes mellitus (for patients undergoing optional PET)
- Patients with controlled diabetes mellitus must have a fasting blood glucose no
greater than 200 mg/dL
- No contraindications to MRI or CT scan (e.g., intracranial vascular clips)
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Prior biopsy or surgery allowed provided no more than 2 months has passed since the
procedure
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Diagnostic
Principal Investigator
Marilyn J. Siegel, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mallinckrodt Institute of Radiology at Washington University Medical Center
Authority:
United States: Federal Government
Study ID:
CDR0000339811
NCT ID:
NCT00072488
Start Date:
October 2004
Completion Date:
Related Keywords:
- Lymphoma
- Neuroblastoma
- Sarcoma
- disseminated neuroblastoma
- localized resectable neuroblastoma
- localized unresectable neuroblastoma
- regional neuroblastoma
- stage 4S neuroblastoma
- previously untreated childhood rhabdomyosarcoma
- stage I childhood Hodgkin lymphoma
- stage I childhood large cell lymphoma
- stage I childhood lymphoblastic lymphoma
- stage I childhood small noncleaved cell lymphoma
- stage II childhood Hodgkin lymphoma
- stage II childhood large cell lymphoma
- stage II childhood lymphoblastic lymphoma
- stage II childhood small noncleaved cell lymphoma
- stage III childhood Hodgkin lymphoma
- stage III childhood large cell lymphoma
- stage III childhood lymphoblastic lymphoma
- stage III childhood small noncleaved cell lymphoma
- stage IV childhood Hodgkin lymphoma
- stage IV childhood large cell lymphoma
- stage IV childhood lymphoblastic lymphoma
- stage IV childhood small noncleaved cell lymphoma
- localized Ewing sarcoma/peripheral primitive neuroectodermal tumor
- metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
- previously treated childhood rhabdomyosarcoma
- Lymphoma
- Neuroblastoma
- Lymphoma, Non-Hodgkin
- Neuroectodermal Tumors, Primitive, Peripheral
- Sarcoma
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
| Nemours Children's Clinic | Jacksonville, Florida 32207 |
| Children's Memorial Hospital - Chicago | Chicago, Illinois 60614 |
| St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
| Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
| Children's Hospital Center for Cancer and Blood Disorders | Aurora, Colorado 80045 |
| AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | Atlanta, Georgia 30322 |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
| Riley's Children Cancer Center at Riley Hospital for Children | Indianapolis, Indiana 46202-5225 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami, Florida 33136 |
| Mallinckrodt Institute of Radiology at Washington University Medical Center | St. Louis, Missouri 63110 |
| Hasbro Children's Hospital | Providence, Rhode Island 02903 |
